Clearance Summary
MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM received FDA 510(k) clearance under submission number K073307, sponsored by Bio-Technology USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-10-29.
- Submission: K073307
- Applicant / Sponsor: Bio-Technology USA, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2008-10-29
Classification & Regulation
This clearance is catalogued under FDA product code JEY and 21 CFR 872.4760, within the Dental review panel as a Class II device.